Introduction
The Central Drugs Standard Control Organisation (CDSCO) has recently updated its regulatory framework to streamline the role of subsequent importers of medical devices in India. This move directly impacts manufacturers, authorized representatives, and distributors who rely on multiple import partners. At Bioexcel, we’ve broken down what this new provision means, why it matters, and how you can stay compliant.
Who is a Subsequent Importer?
A subsequent importer is an entity (other than the primary importer) that brings in the same medical device into India under an already registered manufacturing license. In simple terms, once the product has regulatory approval, multiple importers can distribute it in the country — but with stricter oversight under CDSCO’s latest rules.
The Key Changes Introduced
Mandatory Registration
- Every subsequent importer must now obtain a registration certificate from CDSCO, even if the device is already registered by the primary importer.
- This eliminates loopholes where secondary distributors previously operated under the umbrella of the first importer.
Alignment with Device Master File (DMF)
- Subsequent importers must ensure that all submissions — device details, labelling, and quality certificates — match the DMF and Plant Master File (PMF) of the overseas manufacturer.
Clear Accountability
- Both the primary and subsequent importers will now be individually responsible for product quality, vigilance reporting, and post-market surveillance.
Fees & Documentation
- A separate fee structure has been defined for subsequent importer applications.
Typical documentation includes:
- Power of Attorney from the manufacturer
- Valid ISO 13485/QMS certificates
- FSC (Free Sale Certificate)
- CE/USFDA approvals (if applicable)
- Import license application via CDSCO portal (SUGAM).
Why This Provision Matters
- Transparency & Traceability: Helps CDSCO track every channel through which devices enter India.
- Enhanced Vigilance: Ensures that adverse event reporting and product recalls can be traced to each responsible importer.
- Level Playing Field: Prevents unfair advantage for non-registered secondary importers.
Bioexcel’s Perspective
At Bioexcel, we see this as a positive step toward strengthening India’s regulatory ecosystem. It not only builds trust with healthcare providers but also reassures patients about the safety and performance of imported devices.
Our team helps manufacturers and importers with:
- Preparing and submitting subsequent importer applications
- Aligning DMF/PMF with CDSCO expectations
- Managing post-market surveillance (PMS) and materiovigilance reporting
- Navigating cost structures and timelines to avoid delays
Conclusion
The CDSCO’s new provision on subsequent importers signals a shift toward stricter compliance and accountability in India’s medical device market. For manufacturers and distributors, this means more paperwork but also more credibility. Partnering with regulatory experts like Bioexcel can ensure a smooth transition to this new framework.
Need help with your subsequent importer registration?
Contact Bioexcel today and let our experts handle the compliance while you focus on growing your business.
